Tag : u.s. food and drug administration

Neurology

FDA OKs First Once-Daily IV COX-2 Preferential NSAID for Pain

Newsemia
The FDA approved meloxicam injection (Anjeso, Baudax Bio) for the treatment of moderate to severe pain, either by itself or with other NSAID analgesics. FDA...
Neurology

Suicidal Patients Often Excluded From Antidepressant Trials

Newsemia
Clinical trials of antidepressants that inform FDA approval decisions often exclude suicidal patients, leaving clinicians uncertain of the efficacy of these drugs in this patient...
Neurology

Are FDA Panel Votes on Psych Drugs Tainted by Speakers' COIs?

Newsemia
Members of the public who receive expenses from pharmaceutical study sponsors to attend FDA advisory panel meetings to testify about new psychiatric drugs are highly...
Neurology

Maybe Memorizing the Krebs Cycle Was Worthwhile After All

Newsemia
Mitochondrial disorders are often difficult to diagnose and treat due to their multisystem nature. As scientists better understand mitochondrial function, effective treatments are beginning to...
Neurology

Levetiracetam Oral Solution Recalled in US

Newsemia
Lannett Company has recalled two lots of the anticonvulsant because of microbial contamination, which was identified during an evaluation of a raw material used to...
Neurology

FDA Okays Cenobamate (Xcopri) for Focal Epilepsy

Newsemia
The FDA has approved cenobamate for seizures in adults with focal epilepsy based on results from two trials of more than 600 patients, as well...
Neurology

SUNFISH: Risdiplam Meets Primary Endpoint in SMA

Newsemia
Risdiplam, an oral investigational agent designed to increase and sustain SMN protein levels of patients with spinal muscular atrophy (SMA), met the primary endpoint in...
Neurology

FDA Approves Botox for Lower-Limb Spasticity in Children

Newsemia
The FDA has approved Botox to ease lower-limb spasticity in children and adolescents aged 2 to 17 years, excluding spasticity caused by cerebral palsy. FDA...
Neurology

FDA Okays Pitolisant (Wakix) for Narcolepsy

Newsemia
The FDA has approved pitolisant, a first-in-class, nonscheduled treatment option with a novel mechanism of action for adults with narcolepsy. FDA Approvals Source link...
Neurology

FDA OKs Botox for Upper Limb Spasticity in Children

Newsemia
Botox is the first neurotoxin to be approved in the US to treat upper limb spasticity for pediatric patients aged 2 years and older. FDA...
Neurology

ORACLE-MS: Cladribine Effective in MS Subgroups

Newsemia
The recently approved disease-modifying therapy is expected to find a niche for patients with multiple sclerosis who fail other agents. Medscape Medical News Source link...
Neurology

FDA Clears First Soft Robotic Exo-Suit for Stroke Rehab

Newsemia
The ReStore system is designed like a garment that connects to waist pack and cables that help lift the patient’s affected leg in synchronized timing...
Neurology

FDA OKs Dalteparin (Fragmin), First Anticoagulant for Pediatric VTE

Newsemia
The low-molecular-weight heparin is indicated to reduce the recurrence of symptomatic venous thromboembolism in children as young as 1 month. FDA Approvals Source link...
Neurology

FDA Approves First Vaccine for Dengue, With Restrictions

Newsemia
Dengvaxia is for the prevention of dengue disease caused by all dengue virus serotypes in people aged 9 to 16 years who have previously had...
Neurology

PREVENT: Eculizumab May Lower Relapse Risk in NMOSD

Newsemia
Use of eculizumab resulted in significantly greater relapse reduction over placebo in patients with neuromyelitis optica spectrum disorder (NMSOD), new findings from the phase 3...

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